Allurion Technologies, Inc. (NYSE: ALUR) shares gained ground Wednesday. The company, purporting to be a pioneer in metabolically healthy weight loss, today announced its financial results for the third quarter and provided a business update.
Allurion successfully passed U.S. Food and Drug Administration Pre-Approval Inspection and Bioresearch Monitoring (BIMO) audit with zero observations and no Form 483 issued
It also completed Premarket Approval Acceptance and Filing Reviews, entered Substantive Review for the Allurion Smart Capsule and successfully completed Day-100 meeting.
Allurion also entered into transaction to exchange all outstanding debt for convertible preferred equity and concurrently announced private placement financing of $5 million to strengthen balance sheet
Explored initial development of drug-eluting intragastric device and process validation of new R&D and manufacturing line in collaboration with strategic partner
Operating expenses of $10.9 million and operating loss of $9.6 million reduced by 29% and 22%, respectively, compared to last year. Adjusted operating expenses of $8.4 million and operating loss of $6.9 million reduced by 42% and 39%, respectively, compared to last year.
Said CEO Santanu Gaur, “In this past quarter at Allurion, we achieved several significant milestones toward FDA approval.
“From July through October, we passed two FDA inspections with zero observations and successfully conducted our Day-100 meeting. We believe that we are now entering the final stages of the process.”
ALUR shares gained three cents, or 2.1%, to $1.52.